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In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.

Condition or disease

Intervention/treatment

Phase

Brain Neoplasms

Device: MRI-Guided Laser Induced Thermal Therapy

Phase 1Phase 2

Detailed Description:

The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) to the tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment.

The Visualase Thermal Therapy System will be used in this study to give subjects a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.

LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor

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Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient or family able and willing to give informed consent.

Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).

Three or fewer previously treated or untreated lesion(s) in the brain.

Tumor size ≤ 3.0 cm in largest diameter.

MR imaging is not contraindicated for the patient.

Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.

Able and willing to attend all study visits.

Karnofsky Performance Scale score >70 for patients over the age of 15.